Cleared Traditional

K051781 - GRAFTCAGE TLX

K051781 is the FDA 510(k) clearance for GRAFTCAGE TLX by Osteotech, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K051781 · Osteotech, Inc. · Orthopedic device
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Dec 2005
Decision
168d
Days
Class 2
Risk

K051781 is an FDA 510(k) clearance for the GRAFTCAGE TLX. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteotech, Inc. devices

Submission Details

510(k) Number K051781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date December 16, 2005
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 159
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K051781.
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · Medtronic Sofamor Danek · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · Stryker Spine · Nov 2005